Associate I
2 meses atrás
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Main activities
- Process the adverse event reports from any source as per client/sponsor agreed plans
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- Data entry of safety data onto adverse event database(s) and tracking systems
- Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- Write patient narratives & code adverse events accurately using MedDRA, if applicable
- Determine listedness against appropriate label (for Marketed products, if applicable)
- Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed
- Ensure case receives appropriate medical review
- Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, if required & as agreed with client during study set-up, within study specified timelines
- Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to
- Maintenance of tracking systems
- Set-up and maintenance of project files and central files for documentation
- Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel, as required, within study specified timelines
- Support with quality review or peer review of the processed reports
- Assist and/or complete the database reconciliation and the associated activities, as applicable
- Maintain study/project level documentation as per the agreed requirements, as applicable
- Support with training of PSS staff and mentor the team as needed
- Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed)
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting and pharmacovigilance
- Assist in the preparation for client meetings and liaise with client contacts, where appropriate
- Assist in Quality issues management and support audit and inspection preparation, as needed
- Ensure compliance of operations with governing regulatory requirements and applicable study/project plans, and take responsibility for quality of data processed
- Assist in the preparation of client meetings and liaise with clients where appropriate
- Any other duties as assigned by management.
- Requirements- Bachelors Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.-
- Advanced English-
- Previous experience working in CRO / Pharmaceutical industries in the safety / regulatory / pharmacovigilance areasFortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
-
Quality Control Associate I
Há 2 dias
Sao Paulo, Brasil Johnson & Johnson Tempo inteiroNa **Johnson & Johnson **, a maior empresa de saúde do mundo, nos reunimos com um propósito: transformar a história da saúde humana. Diversidade e inclusão são essenciais para continuar construindo nossa história de pioneirismo e inovação, que tem impactado a saúde de mais de 1 bilhão de pacientes e consumidores todos os dias por mais de 130...
-
Production Associate
2 semanas atrás
Sao Paulo, Brasil Cummins Inc. Tempo inteiro**PRODUCTION ASSOCIATE - LEVEL I** **Description** Operates machines and production equipment in accordance with quality and productivity requirements safely in a manufacturing environment with direct guidance. Health, Safety & Environmental (HSE) Stop work and immediately report any major injury hazards. Report any work-related injury, illness,...
-
Clinical Quality Associate I
2 meses atrás
Sao Paulo, Brasil Curebase Tempo inteiro**About the role**: Curebase is seeking a Clinical Quality Associate I who will thrive in a quickly scaling healthcare technology environment. Quality at Curebase is deeply cross-functional, and you will work with nearly every function at the company to conduct risk-based quality management (RBQM) surveillance of Clinical Operations activities at Curebase....
-
Transaction Processing Associate I
2 semanas atrás
Sao Paulo, Brasil CONDUENT Tempo inteiro**About Conduent**: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture...
-
Customer Experience Associate I
2 semanas atrás
Sao Paulo, Brasil CONDUENT Tempo inteiro**About Conduent**: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture...
-
Customer Experience Associate I
2 semanas atrás
Sao Paulo, Brasil Conduent Tempo inteiroThrough our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. - You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is...
-
Customer Experience Associate I
1 semana atrás
Sao Paulo, Brasil CONDUENT Tempo inteiro**About Conduent**: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture...
-
Transaction Processing Associate I
1 semana atrás
Sao Paulo, Brasil CONDUENT Tempo inteiro**About Conduent**: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture...
-
Initiation Clinical Research Associate I
2 meses atrás
Sao Paulo, Brasil Parexel Tempo inteiroWorking from home with occasional days in our office location in Sao Paulo, as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites located throughout South America and accountable for quality and delivery during the start-up phase. Duties will include EC submissions / site activation related...
-
Analyst/Associate em International Tax
2 meses atrás
Sao Paulo, Brasil Alvarez and Marsal Tempo inteiroDescription Anlises voltadas a tributao em remessas cross-border, estruturas de investimento internacional, estruturas de funding (equity vs. debt) e repatriao (dividendos, juros, royalties, servios etc.).Participao em projetos de reorganizao, suportando as anlises fiscais (planejamento tributrio envolvendo regimes de tributao, utilizao de prejuzos fiscais...
-
Analyst/Associate em International Tax
3 semanas atrás
Sao Paulo, Brasil Alvarez and Marsal Tempo inteiroDescription Análises voltadas a tributação em remessas cross-border, estruturas de investimento internacional, estruturas de funding (equity vs. debt) e repatriação (dividendos, juros, royalties, serviços etc.).Participação em projetos de reorganização, suportando as análises fiscais (planejamento tributário envolvendo regimes de tributação,...
-
Clinical Research Associate I
1 semana atrás
Sao Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION PREFERRED EXPERIENCE: Pharmaceutical/Biotech Industry, Hematology, Oncology Company Overview: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over...
-
Site Management Associate I
Há 11 horas
Sao Paulo, Brasil ICON plc Tempo inteiro**Site Management Associate I** **JR102471** **Site: São Paulo - Brazil** *** At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as...
-
Customer Experience Associate I
3 semanas atrás
SÃO PAULO, Brasil Conduent do Brasil Serviços de Call Center Ltda. Tempo inteiroThrough our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is...
-
Quality Assurance Associate I
3 semanas atrás
São Paulo, Brasil Marken Tempo inteiroDescription Title: Quality Assurance Associate I Job Purpose: To mainly provide support to the QMS, Investigations, Trainings, Vendor qualification process and records review. Main Duties and Responsibilities: Maintain the culture of the importance of an integrated quality system within the company Trainer of topics related to...
-
Quality Assurance Associate I
1 semana atrás
São Paulo, Brasil Marken Tempo inteiroDescription Title: Quality Assurance Associate I Job Purpose: To mainly provide support to the QMS, Investigations, Trainings, Vendor qualification process and records review. Main Duties and Responsibilities: Maintain the culture of the importance of an integrated quality system within the company Trainer of topics related to...
-
Associate Finance Director
Há 1 mês
Sao Paulo, Brasil Biogen Tempo inteiro**Job Description**: As our Associate Finance Director your responsibility contemplates, but is not limited to: - Develop and further refine the Brazil vision and strategy that incorporates business opportunities to achieve 2024 revenue (LRP); - Be a trusted Business Partner to the Brazil team, providing sound financial planning and decision support, while...
-
Associate Delivery Model I&cp
2 meses atrás
Sao Paulo, Brasil Alvarez and Marsal Tempo inteiro**Description** **Infrastructure & Capital Projects (I&CP)** A área tem como objetivo atuar em todo o ciclo de vida de projetos de capital intensivo (grandes empreendimentos, projetos de logística, mineração, energia, O&G, entre outros). A atuação da A&M vai desde o suporte a estruturação de projetos, participação em processos M&A relacionados a...
-
Account Services Associate I
2 meses atrás
Sao Paulo, Brasil FIS Global Tempo inteiro**Position Type**: Full time **Type Of Hire**: Experienced (relevant combo of work and education) **Education Desired**: General Equivalency Diploma **Travel Percentage**: 0% We are FIS. Our technology powers the world’s economy and our teams bring innovation to life. We champion diversity to deliver the best products and solutions for our colleagues,...
-
Account Services Associate I
1 semana atrás
Sao Paulo, Brasil FIS Global Tempo inteiro**Position Type**: Full time **Type Of Hire**: Experienced (relevant combo of work and education) **Education Desired**: General Equivalency Diploma **Travel Percentage**: 0% We are FIS. Our technology powers the world’s economy and our teams bring innovation to life. We champion diversity to deliver the best products and solutions for our colleagues,...
